FDA recall D-0788-2020

Product

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Reason for recall

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2020-01-14

Report date

2020-01-22

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2020